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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION, TAKAHAGI PLANT VISCO-3 ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION, TAKAHAGI PLANT VISCO-3 ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Pt reports after completion of therapy that visco did not work. No further info provided. Reported to (b)(6) by pt/ caregiver.
 
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Brand NameVISCO-3
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key10553287
MDR Text Key207725233
Report NumberMW5096742
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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